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CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.
On Nov. 16, 2022, Theragent, a newly emerged, US-based cell therapy contract development and manufacturing organization (CDMO), announced that CellVax Therapeutics, a French late-stage clinical-trial company, selected it to provide manufacturing and testing services for CellVax’s novel cancer immunotherapy candidate, FK-PC101. FK-PC101 is entering Phase II clinical trials.
The immunotherapy candidate is a cell based autologous cancer vaccine for prostate cancer. It is intended for patients who have a high risk of recurrence after prostatectomy. Under the agreement, the two companies have begun preparations for the manufacturing partnership, including project planning and analytical method tech transfer. Manufacturing services will start in late 2022. Theragent has agreed to supply autologous cell-derived doses to support CellVax’s early and pivotal trials in the United States.
“Theragent is a newer CDMO, but we have assembled a team that brings decades of experience in the development and production of autologous cell-based products around the world,” said Jeff Masten, chief operating officer, Theragent, in a company press release. “We are thrilled to support CellVax and their promising Phase [II] cancer vaccine candidate. Not only does this project fit seamlessly into our new … [C]GMP [current good manufacturing practice] manufacturing facility in Southern California, but the incredible science behind FK-PC101 is a harmonious fit with our company mission of delivering advanced medicines to cancer patients in need.”
“With our proprietary immunotherapy platform, we modify the patient’s tumor cells ex vivo, inducing them to behave as antigen-presenting cells, which are then formulated into a personalized cancer vaccine for that individual. We look forward to partnering with Theragent on the further development of this truly novel modality,” said Fernando Kreutz, CEO of CellVax, in the press release.